History

History

1. 2010

   Company established. Development of the NiTi Brush begins.

   The inspiration of NiTi Brush for peri-implantitis was supplied through a meeting with two ITI fellows — Professor Dr. Baek-Soo Lee, Department of Oral and Maxillofacial Surgery, Kyung-Hee University, Seoul, Korea, and DDS, PhD, FITI, oral surgeon Yasushi Nakajima in Osaka, Japan.

2. 2011

   First patent application filed (November 2011). FDA establishment registration and device listing completed. Sales start in the USA.

   Met the first customer in Germany (Jürgen Becker, Department of Oral Surgery, Westdeutsche Kieferklinik, Universitätsklinikum Düsseldorf, 40225 Düsseldorf, Germany) during the 2nd Implant Expo, Dresden, Germany, 2011.

3. 2012

   The clinical success case of NiTi Brush for peri-implantitis by Prof. Dr. Baek-Soo Lee in Korea.

4. 2013

   CE Class IIa marking for NiTi Brush; sales start in the EU.

5. 2014

   Registration with the Ministry of Health, Labour and Welfare (MHLW) of Japan completed; sales start in Japan.

   First literature in Japan — “Comparison of Mechanical Removal Method on HA Coated Implant Surface”. Akihiro Suzuki, Motohiro Munakata, Tsuyoshi Matsuura, Noriko Tachikawa, Shohei Kasugai (Oral Implantology and Regenerative Oral Medicine, Tokyo Medical and Dental University; Department of Prosthodontic Dentistry for Function of TMJ and Occlusion, Kanagawa Dental University).

6. 2015

   First publication in the USA.

   Atlas of Oral & Maxillofacial Surgery 2015 · Cementation on Dental Implantology (2015).

7. 2016

   First literature in Italy by Dr. Mario Roccuzzo.

   “I often use NiTi Brush to clean and decontaminate the surface of the implants affected by peri-implantitis, before attempting a regenerative procedure. Its reduced dimension allow me to reach every area, even if the space is limited.”

8. 2017

   Scientific literatures of NiTi Brush in leading countries of the EU.

9. 2018

   Full line-up of NiTi Brush models — Nano, Pocket and Omega.

10. 2019

    Renewal of the CE Class IIa certificate.

11. 2020

    Set up the distribution network in Scandinavia & Denmark.

12. 2021

    Set up the distribution network in BENELUX.

13. 2022

    INNO-Biz Certificate.

14. 2023

    Global Leading Company of Korea 1,000+.

15. 2024

    Transition to the EU MDR begins. Manufacturing moves to a new facility; biological evaluation completed; MDR application filed.

    Production was relocated to a plant built for MDR-conformant manufacture, biological evaluation to the ISO 10993 series was completed, and the application for certification under Regulation (EU) 2017/745 was submitted.

16. 2026

    MDR on-site audit conducted (June). Technical file review scheduled for completion by the end of December.

    The notified body audited the manufacturing site and the quality management system in June 2026. Review of the Technical Construction File is scheduled to conclude by the end of December 2026.

17. 2027

    MDR certificate expected. Planned

    Approximately two years before the MDD transitional period ends on 31 December 2028. Dates from December 2026 onward depend on the notified body's review and are not a guarantee — see the transition timeline.

Regulatory status

NiTi Brush for Peri-implantitis is a Class IIa medical device, GMDN 57955 — dental implant debridement brush.

Certificates are provided to distributors and regulatory authorities on request. Registration status differs by country — please confirm with us or with your local authorised distributor before importing.

The reference instrument

Fifteen years of continuous manufacture have put the NiTi Brush in an unusual position: it is not only sold into the field, it is the instrument the field measures against.

• Named by the manufacturer in independent peer-reviewed papers. Research groups that have no commercial relationship with us identify the instrument by name — for example “a titanium brush (Hans Korea Co., Ltd.)” and “NiTi Brush Omega, Hans Korea” — rather than describing a generic device.
• Used as the mechanical baseline in multicentre randomised trials. When newer decontamination technologies are evaluated, the trial design frequently places them on top of mechanical debridement performed with this instrument. Being the control arm is a form of recognition that cannot be bought.
• Counted to a deliberately strict standard. The sixteen publications on our Literature page are only those we have read in full, verified against the publisher's record, and in which the instrument is identifiable as the NiTi Brush from HANS Korea. Papers that report merely “a titanium brush” are not counted, even where we have reason to believe it was ours. The figure is therefore a floor; when a paper names the instrument, we add it.
• Regulatory depth. CE marking held since the MDD era with an MDR transition already under way, Instructions for Use published in nineteen languages, and an established EU authorised representative — the groundwork a new entrant would need years to reproduce.

Transition to the EU MDR

The current CE certificate was issued under the Medical Device Directive and runs to 31 December 2028 under the transitional provisions of Regulation (EU) 2023/607. HANS Korea began the transition to Regulation (EU) 2017/745 (MDR) in 2024 and is working to a certificate well ahead of that deadline.

1. 2024  ·  Foundations laid Completed

   Manufacturing relocated to a new facility built for MDR-conformant production; biological evaluation to the ISO 10993 series completed; the MDR application filed.

2. June 2026  ·  On-site audit Conducted

   The notified body carried out the MDR on-site audit of the manufacturing site and quality management system.

3. December 2026  ·  Technical file review Planned

   Review of the Technical Construction File scheduled for completion by the end of December 2026.

4. 2027  ·  MDR certificate Expected

   Issue of the MDR certificate is expected during 2027 — approximately two years before the MDD transitional period ends.

Dates from December 2026 onward are the current plan and depend on the notified body's review; they are not a guarantee. Distributors and partners who need the current status in writing should contact info@nitibrush.com.

Epilogue 13 years journey of NiTi Brush for peri-implantitis

In 2010, two ITI fellows — Professor Dr. Baek-Soo Lee and DDS, PhD, FITI Yasushi Nakajima — and I (HANS Kim, owner of HANS Korea) discussed the topic of peri-implantitis over sake in Osaka, Japan, until the early morning. That is the starting point of the NiTi Brush for peri-implantitis.

From the autumn of 2011, I started business trips for the promotion of “NiTi Brush for peri-implantitis”. Prof. Hom-Lay Wang (The University of Michigan School of Dentistry) was the first professor who started to use the NiTi Brush for peri-implantitis in the USA. At the same time, during AAP 2011, a representative of Institut Straumann AG visited the HANS Korea exhibition booth for a discussion of NiTi Brush. But at that time “NiTi Brush for peri-implantitis” was not a completed product, and the scientific evidence was not yet sufficient.

Prof. J. Becker was the first professor who picked up the NiTi Brush in Europe during the 2nd Implant Expo 2011, Dresden, Germany. And Dr. Mario Roccuzzo was the first doctor who released the first literature for “NiTi Brush for peri-implantitis” in Europe. Now, NiTi Brush for peri-implantitis is an important material of the “Hands-on course of Dr. Mario Roccuzzo” from 2017.

Some doctors said to me “Prof. Frank Schwarz is lecturing on your NiTi Brush in the lecture hall, do you know it?” at EuroPerio9, RAI, Amsterdam, Netherlands, 2018. I had never met Prof. Frank Schwarz, but it is a fact.

Now we have set up the distribution network in the USA, West EU, North EU, Japan, Benelux and so on. Thirteen years of a long journey with sincere effort makes “NiTi Brush for peri-implantitis” a trustful solution for peri-implantitis, together with a completed product range and reliable scientific evidence produced by key opinion leaders of implantology.